The following data is part of a premarket notification filed by Bio/data Corp. with the FDA for Platelet Aggregation Profiler #pap-4.
| Device ID | K821005 |
| 510k Number | K821005 |
| Device Name: | PLATELET AGGREGATION PROFILER #PAP-4 |
| Classification | Aggregrometer, Platelet |
| Applicant | BIO/DATA CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JBX |
| CFR Regulation Number | 864.6675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-12 |
| Decision Date | 1982-06-01 |